Status:
RECRUITING
AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases
Lead Sponsor:
Fudan University
Conditions:
NSCLC (Advanced Non-small Cell Lung Cancer)
Brain Metastasases
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopat...
Eligibility Criteria
Inclusion
- Pathologically confirmed non-small cell lung cancer;
- clinical stage IV (AJCC, 8th edition, 2017);
- EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion;
- age≥18 years old;
- KPS score≥70;
- brain metastases at diagnosis;
- complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
- received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
- willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
- informed consent of the patient.
Exclusion
- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
- EGFR sensitive mutations were negative or EGFR mutation status was not detected.
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06604689
Start Date
September 30 2024
End Date
October 1 2025
Last Update
November 12 2024
Active Locations (1)
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1
Shanghai Cancer center
Shanghai, Shanghai Municipality, China, 200050